IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Oxytocin; Drug: Oxytocin

Detailed Description

The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

• Study Type: Interventional
• Enrollment (Actual): 653
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ecuador
  • Quito, Ecuador
    • Hospital Gineco-Obstétrico Isidro Ayora
• Turkey
  • Ankara, Turkey
    • SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Huong Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion Criteria: Women who are:

• Planned or transferred for delivery via Cesarean section
• Not delivering a live birth
• Unable to provide informed consent due to mental impairment, distress during labor or other reason
• Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV infusion; Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.	Drug: Oxytocin; 10 IU oxytocin in 500 ml infusion; Drug: Oxytocin; 10 IU oxytocin IM injection
Active Comparator: IM Injection; Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.	Drug: Oxytocin; 10 IU oxytocin in 500 ml infusion; Drug: Oxytocin; 10 IU oxytocin IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean blood loss (ml)	minimum of 1 hour after delivery of baby

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml		minimum of 1 hour after delivery of baby
Change in hemoglobin from pre-delivery to postpartum	Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.	12-24 hours after delivery
Time to placental delivery		minimum of 1 hour after delivery of baby
Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy		minimum of 1 hour after delivery of baby
Side effects 1 hour postpartum		1 hour postpartum
Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward		arrival to labor ward

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Center for Research and Consultancy in Reproductive Health; Huong Vuong Hospital; MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
• Investigators: Principal Investigator: Jill Durocher, Gynuity Health Projects; Principal Investigator: Ilana Dzuba, MHS, Gynuity Health Projects

Publications and helpful links

General Publications

• Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: March 25, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Oxytocin; Prevention; Hemoglobin; Intravenous; Postpartum hemorrhage; Intramuscular; Third stage of labor
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 3000